The present invention relates to a medical tube inserting device for ensuring safely and infallibly a route for drainage of digestive juices and infusion of drug solution, enteral nutrition and the like, and particularly, a balloon catheter for puncturing endowed with a function so that it does not rupture immediately by puncturing thereby ensuring lumen, and structures of tube inserting devices including the above-described catheter and a method for use thereof.
Conventionally, particularly as a method for enteral nutrition dosage, a pediatric surgeon Gaudert and an endoscope surgeon Ponsky developed percutaneous endoscopic gastrostomy (PEG) in 1979 which is an endoscopic surgery for forming fistula opening on the surface of lumen of stomach and abdominal wall skin using an endoscope (Japanese Patent Application National Publication Laid-Open No. 6-503243), further, some technologies for applying this technology have been developed and are in widespread use. However, this is not to mention that this technology is restricted to doctors who can handle an endoscope. Also, this technology is restricted by cases and can not be used or use thereof is difficult in cases such as xe2x80x9cwhen massive ascites are storedxe2x80x9d, xe2x80x9cwhen liver and transverse colon are present between stomach and abdominal wallxe2x80x9d, xe2x80x9cafter a gastrectomy,xe2x80x9d and the like since stomach walls and abdominal walls are needled.
Further, there is a method with a nasal gastric tube; however, when indwelling lasts for a long period of time, pain in naris, nasal cavity and pharynx may increase and ulcers may be formed in the naris which makes continuous indwelling difficult, and further, pneumonia may even coincide due to difficulty of expectoration.
The method is also not preferable from these standpoints in view of QUALITY OF LIFE.
Further, in 1983, Allem. S. Chen et al. have suggested in the United States a method in which a bulb or optical fiber or magnet is installed in a balloon, a tube equipped with the balloon is inserted via nose, a cervical area is needled using a detector for detecting transmitted light or magnetic wave at the cervical area, and an esophagostomy is made for indwelling of a nutrition tube. In Japan, Nakano et al. developed a method for making an esophagostomy under X-ray fluoroscopy in 1993. In this indwelling method, a tube equipped with a balloon is inserted into an esophagus via the nose, a contrast medium is injected into the balloon in the cervical esophagus to expand lumen of the cervical esophagus, then, the cervical esophagus is needled percutaneously under X-ray fluoroscopy, and an esophagostomy is made for indwelling of a nutrition tube. The indwelling method of Nakano is simple, imparts minimal invasion and pain to patients and is useful for nutrition control for a long period of time, however, in this method, puncturing is conducted only under X-ray fluoroscopy and there is a possibility of danger in view of the anatomical structure of cervix. Further, in any of the suggested two methods, a balloon catheter is used having a tube equipped with a balloon which ruptures when punctured; therefore, in the puncturing, whether the puncturing needle reaches the esophagus lumen or not is determined by the puncturing of the balloon, and there is a danger that the leading point of the needle, after puncturing, injures the esophageal wall or the puncturing needle releases from the esophageal wall due to the esophagus collapsing.
On the other hand, the present inventor Oishi et al. improved the method of Nakano et al. in which a an esophagostomy is formed under X-ray fluoroscopy, and invented, as a method for needling a balloon of a balloon catheter, a method in which a balloon is needled with a puncturing needle safely and infallibly while externally confirming position of the balloon using a ultrasonic probe (xe2x80x9cRegarding Percutaneous Trans-esophageal Gastro-tubing, Application and Utility Thereofxe2x80x9d, Journal of Japan Surgical Society, 1997. xe2x80x9cRegarding Esophageal Gastro-tubing, Knack and Side-injury Percutaneous Trans Thereofxe2x80x9d, The Japanese Journal of Gastroenterological Surgery, 1997.). However, in this method, the danger that the leading point of the needle after puncturing of the balloon injures the esophageal wall or the puncturing needle releases from the esophageal wall remains, since a Foley catheter which causes rupture by puncturing is used similar to the method of Nakano.
The present invention has been made in view of the above-described conditions, and the object thereof is to provide a medical tube inserting device for ensuring safely and infallibly a route for drainage of digestive juices and infusion of drug solution, enteral nutrition and the like, and more specifically, a balloon catheter for puncturing having no danger that the leading point of a needle injures the esophageal wall and the like or the puncturing needle releases from the esophageal wall and the like, a medical tube inserting device using this catheter, and a method for use thereof.
Namely, the balloon catheter for puncturing of the present invention provided an intending solution of the above-described problems is a balloon catheter for puncturing which is inserted through a puncture area in a body via nose and the like, expanded by fluid such as physiological saline and the like and needled, wherein the above-described balloon is so constituted that when it is needled externally by a puncturing needle, it does not rupture immediately and lumen can be ensured. More specifically, the balloon has a thickness of 0.01 to 1 mm, a tensile strength of 8 to 25 MPa, a tear strength of 20 to 60 kg/cm, a 100% modulus of 3 to 6 MPa, an elongation of 300 to 460% and a balloon internal pressure of 2.8 to 75 psi, and does not rupture immediately in needling by a puncturing needle; and a catheter shaft made of a material having remarkably different levels of ultrasound transmission as compared with internal fluid such as physiological saline and the like in the balloon is placed approximately in the center of lumen of the balloon; in addition, for improvement of insertion operation, lumen is provided so that the balloon catheter can be inserted smoothly into a hollow organ along a previously inserted guide wire or a stilet is contained for firming a catheter up; further, for enabling insertion operation without X-ray contrast, graduation is provided on the catheter shaft and a pilot balloon for confirming expansion of the balloon is placed in the vicinity of a connector area.
Owing to the above-described constitution, when a catheter of the present invention is used, a catheter shaft having excellent visibility is situated in the center of the balloon in an ultrasonic echo image in needling; therefore, by adjusting puncturing predetermined lines onto the above-described echo image, not only is simple puncturing enabled but also the above-described balloon does not rupture immediately when punctured; consequently, a danger that a needle injures puncture areas or a needle releases from the puncture areas almost disappears.
In the present invention, the medical tube inserting device provided an intending solution of the above-described, prior art is advanced through the combination of at least a puncturing balloon catheter having the above-described constitution, a puncturing needle equipped with an inner needle for guiding a guide wire on which roughening process or the like is performed for catching clearly an ultrasonic echo image for guiding a guide wire, a guide wire equipped with graduation and the like for tube introduction, a dilator equipped with a sheath for extending the puncture axes, and an indwelling catheter which indwells in stomach mainly via esophagus and effects drainage of digestive juices, infusion of drug solution and the like in which a balloon having an expanded diameter of 20 mm or more is placed at a position about 10 cm from the leading point and at least one side pore is provided on the catheter at the leading point side of the balloon, wherein each is enabled to be inserted even without endoscope or X-ray contrast.
Further, regarding use of the above-described medical tube inserting device of the present invention, specifically, a balloon catheter which does not rupture immediately even by needling is inserted to the puncture area via the nose and the like, a balloon is expanded by fluid such as physiological saline and the like, the balloon is needled by a puncturing needle aiming at a catheter shaft while externally confirming positions of the balloon and the catheter shaft using an ultrasonic probe, a guide wire is inserted into the balloon through the puncturing needle while confirming sure puncturing through transmission of movement to the shaft and outflow of fluid in the balloon from the end of the puncturing needle thereby ensuring lumen by the above-described balloon; the puncturing needle is pulled out, the balloon catheter for puncturing is proceeded further toward the anal area to forcibly direct the leading point of the guide wire toward anus side and the catheter is retained in the intended area, the puncture area is extended by a dilator equipped with a sheath, the dilator is pulled out, an indwelling catheter equipped with a balloon is inserted via the sheath and the balloon is expanded in the stomach and the like. After pulling the catheter, the operation is fixed to the esophago-cardiac junction for indwelling of the catheter in the intended area and ensuring a route for drainage of digestive juices and infusion of a medical solution and the like. By using the indwelling catheter equipped with a balloon constituted as described above, when, for example, the balloon is expanded in stomach and pulled toward the vicinity of the mouth, the above-described balloon is fixed to the esophago-cardiac junction of the stomach and the leading point of the indwelling catheter can be allowed to indwell at the fundus of the stomach irrespective of a differential in distance between the puncture area and the cardiac region of the stomach between individuals.